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7+ years
Not Disclosed
10 July 16, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Qualified Person for Pharmacovigilance (EU QPPV) – Leinster, Ireland | Flexible/Remote Work

Job Summary:
Thornshaw Recruitment, on behalf of a leading life sciences consultancy, is seeking an experienced Qualified Person for Pharmacovigilance (EU QPPV) to ensure full regulatory compliance across the UK and EEA. This high-responsibility position requires a deep understanding of pharmacovigilance legislation and leadership in overseeing PV systems and regulatory communications. The company offers truly flexible working, empowering team members to work when and where they choose.


Key Responsibilities:

  • Serve as EEA QPPV under EU Directive 2001/83/EC and other applicable regulations

  • Maintain continuous safety profile oversight and identify emerging safety concerns

  • Ensure compliance in safety submissions and PV system management

  • Act as 24/7 point-of-contact with the EMA and other competent authorities

  • Oversee Risk Management Plans (RMPs), PSMFs, and Post-Authorisation Safety Studies (PASS)

  • Support internal audits and regulatory inspections with readiness and training

  • Contribute to CAPAs and safety quality systems as required

  • Lead and influence cross-functional teams and stakeholders on PV matters


Required Skills & Qualifications:

  • Life Sciences degree (mandatory)

  • Minimum 7 years’ experience in the pharmaceutical industry with core PV expertise

  • In-depth knowledge of:

    • Directive 2001/83/EC, Regulations EC 726/2004 & 520/2012

    • Good Pharmacovigilance Practices (GVP) guidelines

    • Human Medicines Regulations 2012, MHRA post-Brexit guidance

    • Medical Device Regulations (Statutory Instruments)

  • Documented experience across all PV functions necessary for QPPV status

  • Demonstrated participation in regulatory inspections and audits

  • Strong leadership, problem-solving, and cross-functional communication skills

  • Must be based and operating in Ireland


Perks & Benefits:

  • Fully flexible working hours and location – Remote/Hybrid/On-site options

  • High-impact leadership role within a supportive and modern work culture

  • Join a growing, agile consultancy committed to regulatory excellence

  • Opportunities for further professional growth and compliance leadership

  • Autonomy from Day 1 and supportive team dynamics


Company Description:

Thornshaw Recruitment, a division of CPL Group, specializes in connecting top talent with life sciences leaders across the pharmaceutical, biotechnology, and healthcare sectors. Their client, a progressive life sciences consultancy, supports global PV compliance and offers a healthy work-life balance driven by flexibility and empowerment.


Work Mode: Remote / Flexible / Leinster-based


Call to Action:

Are you ready to lead pharmacovigilance strategy in a flexible, autonomous role? If you're a seasoned QPPV ready to make a regulatory impact across Europe, apply now or send your CV to tdunne@thornshaw.com and take the next step in your drug safety leadership journey.